Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa (coArtHA)

October 19, 2022 updated by: University Hospital, Basel, Switzerland

Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa - A Randomized Controlled Trial

This study is to compare the effectiveness of three different antihypertensive treatment strategies for reaching a target blood pressure (clinic BP) of </= 130/80 mmHg among patients <65years of age and </= 140/90 mmHg among patients >/=65years of Age in HIV-positive and HIV-negative patients with uncomplicated arterial hypertension in rural Tanzania and Lesotho.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lesotho
      • Mokhotlong, Lesotho
        • SolidarMed Lesotho, Mokhotlong Government Hospital
  • Switzerland
      • Basel, Switzerland, 4031
        • Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel
  • Tanzania
    • Morogoro
      • Ifakara, Morogoro, Tanzania
        • St. Francis Referral Hospital/ Ifakara Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-positive and negative patients of African descent and black ethnicity with a documented uncomplicated, untreated arterial hypertension (blood pressure >/=140/90 mmHg) diagnosed at one of the 2 study sites

Exclusion Criteria:

  • Current hospitalization for any reason
  • Not of African descent
  • Refusal of an HIV-test or indeterminate HIV test result
  • History of cardiovascular event in the last month (anginal pain, stroke, myocardial infarction or diagnosis by a doctor)
  • Symptomatic arterial hypertension (blood pressure >/=180/110 mmHg plus headache or chest pain) or acute cardiovascular event
  • acute disease, (e.g. fever >37.5°C or other signs of acute concomitant infection; Dyspnea/respiratory distress; Acute pain)
  • Clinical signs of hypertension-mediated organ damage (heart failure, bilateral pitting edema, bilateral crackles or pleural effusion, distended jugular veins, ischemic heart disease (anginal pain on exertion), signs of current ischemic/hemorrhagic stroke (hemiparesis, loss of consciousness)
  • Pregnancy (test required for females 18-45years of age)
  • Non-consenting or inability to come for follow-up visits
  • creatinine clearance </=30ml/min by Chronic Kidney Disease Epidemiology Formula (CK-EPI) estimation and measurement with a point-of care creatinine from capillary blood

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention 1: dual combination
dual combination of half-dose Calcium Channel Blocker (CCB) and Angiotensin II Receptor Blocker (ARB), dosage increases at 4 and 8 weeks if target blood pressure is not reached at the respective time point
Other: dual combination
Participants will be started on a dual therapy with half dose of CCB and an ARB. If needed, a) the dose of the CCB will be increased at 4 weeks, and b) the dose of the ARB at 8 weeks, if blood pressure remains uncontrolled ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP 65years)
Active Comparator: Intervention 2: triple combination
triple combination of quarter-dose of Calcium Channel Blocker (CCB), Thiazide diuretic (TZD) and Angiotensin II Receptor Blocker (ARB) with dosage increases of all drugs at 4 and 8 weeks, if target blood pressure is not reached at the respective time point
Other: triple combination
Participants will be started with low dose (1/4) triple combination treatment with CCB, TZD and ARB. If uncontrolled after 4 weeks, dosages of all drugs will be doubled. If after 8 weeks still uncontrolled dosage will be increased to full dose of all three drugs ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP 65years)
Placebo Comparator: Standard of care
start normal dose Calcium Channel Blocker (CCB), add Thiazide diuretic (TZD) after 4weeks and increase of TZD dosage after 8 weeks, if target blood pressure is not reached at the respective time point
Other: Standard of care
Participants will be started on regular dose of CCB with a) addition of TZD at 4 weeks, if needed, b) increase of dose of TZD after 8 weeks, if needed (if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP 65years)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients reaching a target blood pressure
Time Frame: at 12 weeks after enrolment
Proportion of patients reaching a target blood pressure (clinic blood pressure) of </=130/80 mmHg in patients <65years of age and </=140/90 mmHg in patients >65years of age
at 12 weeks after enrolment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients reaching a target blood pressure
Time Frame: at 4, 8 and 24 weeks after enrolment
Proportion of patients reaching a target blood pressure (clinic blood pressure) of </=130/80mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age
at 4, 8 and 24 weeks after enrolment
Change in blood pressure (mmHg)
Time Frame: at 4, 8, 12, 24 weeks after enrolment
Change in blood pressure (change from enrolment) (mmHg)
at 4, 8, 12, 24 weeks after enrolment
Proportion of patients with treatment adaptations made to the primary treatment
Time Frame: within 12 weeks after enrolment
Proportion of patients with treatment adaptations made to the primary treatment (dose increases and/or drug additions)
within 12 weeks after enrolment
Number of treatment adaptations per patient made to the primary treatment
Time Frame: within 12 weeks after enrolment
Number of treatment adaptations per patient made to the primary treatment
within 12 weeks after enrolment
Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age
Time Frame: within 24 weeks after enrolment
Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age
within 24 weeks after enrolment
Proportion of patients with major cardiovascular endpoints
Time Frame: within 24 weeks after enrolment
Proportion of patients with major cardiovascular endpoints such as death, stroke, myocardial infarction, heart failure)
within 24 weeks after enrolment
Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage
Time Frame: within 24 weeks after enrolment
Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening)
within 24 weeks after enrolment
Proportion of patients lost to follow up or stopped treatment
Time Frame: within 24 weeks after enrolment
Proportion of patients lost to follow up or stopped treatment
within 24 weeks after enrolment
Proportion of patients with at least one grade 3/4 adverse event
Time Frame: within 24 weeks after enrolment
Proportion of patients with at least one grade 3/4 adverse event
within 24 weeks after enrolment
Proportion of patients with at least one severe adverse event
Time Frame: within 24 weeks after enrolment
Proportion of patients with at least one severe adverse event
within 24 weeks after enrolment
Proportion of patients who were non-adherent to drugs
Time Frame: at 12 weeks after enrolment
Proportion of patients who were non-adherent to drugs (<90% pill count or <90% of self-reported drug intake)
at 12 weeks after enrolment
Reasons for non-adherence assessed by pill count (descriptive analysis)
Time Frame: within 24 weeks after enrolment
Reasons for non-adherence assessed by pill count (descriptive analysis)
within 24 weeks after enrolment
Cost-effectiveness of the 3 treatment algorithms
Time Frame: within 24 weeks after enrolment
Cost-effectiveness of the 3 treatment algorithms
within 24 weeks after enrolment
Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement
Time Frame: within 12 weeks after enrolment
Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement
within 12 weeks after enrolment
Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age)
Time Frame: within 12 weeks after enrolment
Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age)
within 12 weeks after enrolment
Reasons for non-adherence assessed by self-report (descriptive analysis)
Time Frame: within 24 weeks after enrolment
Reasons for non-adherence assessed by self-report (descriptive analysis)
within 24 weeks after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Fund for Scientific Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maja Weisser Rohacek, PD Dr., Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-00817; qu19Weisser

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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